- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01765101
Therapeutic Effects of Insoles on Patients With Knee Osteoarthritis
9. januar 2013 oppdatert av: Ru-Lan Hsieh, Taipei Medical University
Therapeutic Effects of Ready-made Full-length Lateral Wedged Insoles and Customized Full-length Lateral Wedged Insoles on Patients With Knee Osteoarthritis : a Double Blind, Randomized Controlled Study
Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ready-made full-length lateral wedged shoe insoles and customized full-length lateral wedged shoe insoles to patients with knee osteoarthritis, under the basis of International Classification Functioning, Disability and Health.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
A total of 90 patients will be collected.
The participants will be randomized into two groups, including ready-made full-length lateral wedged shoe insoles group and customized full-length lateral wedged shoe insoles group.
The psychological function (Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire), physical activity (CHAMPS physical activity questionnaire), functional performance (Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score) and quality of life (World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life) will be evaluated.
Physical functional ability (10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time), pain (Visual analog scale, pain pressure threshold ) and balance performance (static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk) will be evaluated before and immediately after the ready-made full-length shoe insoles and customized full-length shoe insoles are prescribed.
All the evaluations, including physical functional ability, pain, balance, psychological, physical activity, functional performance, and quality of life, will be re-evaluated at one month after and three months after modified shoe insoles wearing.
Subjects and evaluator were both blinded to the group's classification during the whole course of study.
Studietype
Intervensjonell
Registrering (Forventet)
90
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Taipei, Taiwan, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- fulfill the combined clinical and radiographic criteria for knee osteoarthritis, as established by the American College of Rheumatology
- with Kellgren-Lawrence scores of 2 or higher in the isolated medial compartment
Exclusion Criteria:
- with a history of previous knee surgery with an implant
- reduced lateral compartment and/or combined medial and lateral compartments in knee joints were excluded
- pregnant or planning to become pregnant
- self-reported history of vertigo, malignancy, stroke, or other conditions that may impair vestibular function
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: customized insoles
customized full-length lateral wedged shoe insoles 1 month and 3 months study the immediate, short-term and intermediate-term therapeutic effects |
To study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance
Andre navn:
|
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Placebo komparator: ready made insoles
ready-made full-length lateral wedged shoe insoles at 1 and 3 months study the immediate, short-term and intermediate-term therapeutic effects |
To study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
pain
Tidsramme: change from baseline at one month and three months after modified shoe insoles wearing
|
Visual analog scale, pain pressure threshold
|
change from baseline at one month and three months after modified shoe insoles wearing
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical functional ability
Tidsramme: change from baseline at one month and three months after modified shoe insoles wearing
|
10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time
|
change from baseline at one month and three months after modified shoe insoles wearing
|
|
psychological function
Tidsramme: change from baseline at one month and three months after modified shoe insoles wearing
|
Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire
|
change from baseline at one month and three months after modified shoe insoles wearing
|
|
functional performance
Tidsramme: change from baseline at one month and three months after modified shoe insoles wearing
|
Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score
|
change from baseline at one month and three months after modified shoe insoles wearing
|
|
quality of life
Tidsramme: change from baseline at one month and three months after modified shoe insoles wearing
|
World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life
|
change from baseline at one month and three months after modified shoe insoles wearing
|
|
balance performance
Tidsramme: change from baseline at one month and three months after modified shoe insoles wearing
|
static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk
|
change from baseline at one month and three months after modified shoe insoles wearing
|
|
physical activity
Tidsramme: change from baseline at one month and three months after modified shoe insoles wearing
|
CHAMPS physical activity questionnaire
|
change from baseline at one month and three months after modified shoe insoles wearing
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ru-Lan Hsieh, MD, Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2013
Primær fullføring (Forventet)
1. desember 2013
Studiet fullført (Forventet)
1. desember 2013
Datoer for studieregistrering
Først innsendt
4. januar 2013
Først innsendt som oppfylte QC-kriteriene
8. januar 2013
Først lagt ut (Anslag)
10. januar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. januar 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. januar 2013
Sist bekreftet
1. januar 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SKH-8302-102-DR-32
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